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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01514487




Registration number
NCT01514487
Ethics application status
Date submitted
17/01/2012
Date registered
23/01/2012
Date last updated
1/03/2017

Titles & IDs
Public title
Comparison of Three Liraglutide Formulations in Healthy Volunteers
Scientific title
A Randomised, Double-blind, Single-centre, Three-period, Cross-over Trial in Healthy Subjects Investigating the Bioequivalence Between Each of the Two New Liraglutide Formulations at pH 7.9 and 8.15 and the Planned Phase 3 Formulation at pH 7.7
Secondary ID [1] 0 0
NN2211-1636
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 0 0
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - liraglutide

Experimental: pH 7.7 -

Experimental: pH 7.9 -

Experimental: pH 8.15 -


Treatment: Drugs: liraglutide
One single dose of 0.75 mg administered on three different dosing occasions with a 14-day wash-out period between each dosing. Injected subtaneously
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Area under the Curve (0-t)
Timepoint [1] 0 0
Primary outcome [2] 0 0
Cmax, maximum concentration
Timepoint [2] 0 0
Secondary outcome [1] 0 0
Area under the curve (0-infinity)
Timepoint [1] 0 0
Secondary outcome [2] 0 0
tmax, time to reach Cmax
Timepoint [2] 0 0
Secondary outcome [3] 0 0
t½, terminal half-life
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Terminal elimination rate constant
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Adverse events
Timepoint [5] 0 0

Eligibility
Key inclusion criteria
- Healthy subjects

- Good general health as judged by the investigator, based on medical history, physical
examination including 12-lead ECG (electrocardiogram), vital signs and blood and
urinary laboratory assessments.

- Body Mass Index (BMI) of 18-27 kg/m^2, both inclusive
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- History of any clinically significant renal, hepatic, cardiovascular, pulmonary,
gastrointestinal,

- metabolic, endocrine, haematological, neurological, psychiatric disease or other major
disorders

- that may interfere with the objectives of the study, as judged by the investigator

- Family or personal history of Primary hyperparathyroidism or pheochromocytoma or
thyroid malignancy or multiple endocrine neoplasia

- Impaired renal function

- Uncontrolled treated/untreated hypertension

- Any clinically significant abnormal ECG

- Active hepatitis B and/or active hepatitis C

- Positive HIV (human immunideficiency virus) antibodies

- Known or suspected allergy to trial product(s) or related products

- Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate
contraceptive measures

- Prescription or non-prescription medication, except for paracetamol and vitamins

- History of alcoholism or drug abuse during the last 12 months

- Smoking of more than 10 cigarettes per day, or the equivalent for other tobacco
products

- Habitual excessive consumption of methylxanthine-containing beverages and foods
(coffee, tea, soft drinks such as cola, chocolate) as judged by the Investigator

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/01/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/03/2005
Sample size
Target
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This trial is conducted in Oceania. The aim of this trial is to test for bioequivalence
between each of the two new liraglutide formulations at pH 7.9 and 8.15 and the planned Phase
3 formulation at pH 7.7.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01514487
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Global Clinical Registry (GCR, 1452)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries